Accounting for the High Enrollment of African Americans on Winship Cancer Institute's Myeloma Clinical Trials.

Background: Thirty-four percent of Multiple Myeloma (MM) clinical trial participants at Winship Cancer Institute (Winship) are African American (AA); however, AAs make up only 4.5 percent of myeloma clinical trial participants in the United States. Given our high enrollment, we aimed to measure AAs' trust in providers and identify if clinical trial enrollment barriers exist. Methodology: A member of the ethics research team surveyed AA patients who had consented to a MM clinical trial at Winship. Three validated surveys were used: Trust in Medical Research (TMR); Human Connection (THC) which measures how much patients feel they are heard and valued by their physicians; and the Duke Intrinsic Religiosity Scale (DUREL) which measures strength of religious engagement and belief. The survey also included questions about the impact of side effects, distance to the trial center and trial related costs on the decision to participate in clinical trial. Results: Ninety-two percent (61/67) of patients approached consented. The mean TMR score and the mean THC score were significantly higher (P-value < 0.001) than the results obtained in key national surveys (TMR 14.9 compared to 11.65; THC 57.7 compared to 54.6). These two surveys were significantly correlated, meaning trust and human connection increase or decrease in tandem. The 3 religiosity subscale results showed high religiosity (3.84, 4.36, and 4.35 with 5 being the highest score). The mean scores of the importance of the investigational agent's side effects, trial costs, and distance to trial center on the decision to enroll in a clinical trial were also high (8.5, 7.8, and 6.5, respectively, with 10 being the most important). Conclusion: In our study population, high trust and human connection overcame other trial participation barriers: strong religious beliefs and concerns about side effects, costs, and travel distance. We present a roadmap to guide investigators to increase human connection, and hopefully trust.

Genetic testing and informed consent.

OBJECTIVES: To discuss unique issues related to cancer predisposition genetic testing and informed consent. DATA SOURCES: Published professional articles, review articles, research articles, clinical practice, position statements, websites, and textbooks. CONCLUSIONS: The discovery of germline mutations that confer a predisposition for the development of cancer will continue. The provision of adequate information is central to the process of genetic counseling and testing so that individuals may give informed consent and make choices appropriate to their own specific circumstances. IMPLICATIONS FOR NURSING PRACTICE: The use of genetic information for the management of cancer will impact the practice of all oncology nurses in the coming years. Knowledge of genes that predispose for cancer and standards that delineate essential components of quality care during the informed consent process is vital.

Informed consent in the Childrens Cancer Group: results of preliminary research.

BACKGROUND: Informed consent is critical to the ethical conduct of pediatric cancer clinical research. Research regarding such consent has been limited. METHODS: After conducting a background survey of institutional practice from principal investigators (PIs) at 113 Childrens Cancer Group (CCG) centers, the authors obtained more detailed data regarding informed consent from 23 parents of children recently enrolled in CCG research trials and from 23 clinician-investigators at 5 CCG institutions. RESULTS: Approximately 73% of PIs responded to the background survey, providing context in which to interpret the more detailed information. Parents reported that they found the informed consent process helpful, although somewhat confusing. Satisfaction with informed consent was not related to ethnicity or education level. Parents found discussion with staff more helpful than the consent document, and the majority reported that the amount of information conveyed was appropriate. Although only 3 parents (13%) reported that too much information was given, nearly 50% of the investigators believed too much information usually is provided. All investigators believed that patients benefit from participation in CCG studies; the majority recommend that the child be enrolled on study, and the majority believe the major obstacle to good informed consent is parents' "state of shock." CONCLUSIONS: Parents expressed general satisfaction with the consent process. By contrast, clinician responses indicate dissatisfaction with the informed consent process. Future research must include more centers and larger numbers of parents of children who we enrolled as well as those who declined to participate in CCG studies, examine consent in minority subgroups, and further investigate the role of clinician-investigators and their interaction with parents and children during the informed consent process.

Experience with a nine-step policy dealing with requests for medically inappropriate interventions for cancer.

The article outlines a nine-step process adopted at The University of Texas MD Anderson Cancer Center for handling patient requests for medically inappropriate interventions. The main step in the process is review by an Institutional Review Committee composed of the physician-in-chief, ethics committee members, and medical experts. The decision of the Review Committee is binding. The experience with this "futility" policy is discussed including a follow-up pilot project conducted by the Department of Gynaecologic Oncology that introduces a standardized advance care planning medical record progress note in which patient preferences about cardiopulmonary resuscitation, mechanical ventilation, and location of death are documented. The note is to be used at the beginning of non-curative therapy and is intended to help to avoid future requests for futile interventions.